BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1392 5.9MM STRYKER SHEATH 2 WAY -NS

    MDR report key: 7638335 · Received June 26, 2018

    Report

    Report Number
    1221934-2018-51104
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Report Date
    April 26, 2013
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HNX
    UDI-DI
    10886705016099
    PMA / PMN Number
    K951702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEAL THAT ALL COMPONENTS ON THE RETURNED SHEATH ARE INTACT AND THERE ARE NO LOOSE OR BROKEN PARTS. THE SCREWS BELOW THE INFLOW/ OUTFLOW VALVES WERE DISASSEMBLED TO CHECK FOR ANY WEAR THAT WOULD CAUSE THIS FAILURE. IT APPEARS THAT ON ONE VALVES, THE THREADS ARE WORN AND CORRODED POSSIBLY FROM THE REPEATED USE & STERILIZATION CYCLES. WHEN ASSEMBLED, THE FIXTURE IS TIGHT AND ALLOWS THE VALVES TO MOVE WITHOUT LOOSENING. THE SCREWS ARE ABLE TO HOLD THE VALVES TIGHTLY IN POSITION WITHOUT ANY DISCREPANCIES AS REPORTED IN THE COMPLAINT. WE CANNOT CONFIRM THIS COMPLAINT AT THIS POINT. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES RELEASED FOR DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. (B)(4). THIS REPORT IS BEING FILED FROM THE REMETREX COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THE SCREWS ON THE CUSTOMER'S HIGH FLOW SHEATH BROKE OFF BELOW THE INFLOW/OUTFLOW VALVE DURING AN UNKNOWN PROCEDURE. HE STATED HE WAS NOT PRESENT DURING THE CASE BUT VERIFIED THAT NOTHING FELL INSIDE THE PATIENT. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED. NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479859 1392 5.9MM STRYKER SHEATH 2 WAY -NS RIGID ENDOSCOPE SHEATH HNX DEPUY MITEK LLC US 44666008 10886705016099

    Patients

    Seq Age Sex Outcome Treatment
    1